FDAFDA · Food and drugs·Recall number Z-0751-2025
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Published January 1, 2025 · Recall initiated: October 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Distributor
- U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
- Lot
- Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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